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01 December 2011

Medical cannabis: Time to trial

Discussion paper Greens MP John Kaye 29 November 2011

The Greens are beginning a process to end 12 years of inaction that followed the 1999 NSW Drug Summit recommendation for a trial of medicinal cannabis.

In November 2011, Greens NSW MP and Health Services spokesperson John Kaye tabled a motion (see Appendix A) in the Upper House calling on the Minister for Health to establish a tightly controlled, carefully monitored one year trial of medically prescribed cannabis.

A trial is well past time given both the growing body of evidence of the therapeutic and palliative benefits of cannabis and changing attitudes in the medical profession and the health sciences research community.

The Greens believe that NSW should explore a compassionate regime to provide relief for those suffering from a range of illnesses without the risk of criminal sanctions. Decisions about the regulation of pharmacological drugs should be based purely on proven therapeutic and palliative effects, regardless of their connections or otherwise to illegal substances.

It is irrational and inhumane to deny many individuals the benefits of a medical cannabis treatment because of an unfounded fear that the palliative or therapeutic use of the product would promote or assist recreational drug use.

This paper outlines the proposed parameters for the trial and provides background on the medical research literature.

It is intended to move the motion in the Autumn 2012 session of the NSW parliament. The motion can be amended and the purpose of this paper is to promote discussion on this important issue and to encourage feedback to the office of John Kaye.

The development of this report is indebted to the many individuals and groups who have campaigned for many years for a trial of medical cannabis. Many ideas have been borrowed from the 2011 PhD thesis1 of Dr Graham Irvine at Southern Cross University.

The Greens' Proposed Medical Cannabis TrialThe November 2011 motion calls on the NSW Minister for Health Jillian Skinner to establish a trial of medical cannabis of one year's duration. The trial scheme envisaged in the motion would be limited to: . the administration of cannabis in tincture form; . a limited, prescribed list of diagnoses; and . patient participation based on a prescription from a General Practitioner or treating Specialist, subsequently submitted to NSW Health for approval. The list of prescribed conditions are proposed to be: . cancer, . AIDS-related severe wasting, . chronic pain, . chronic nausea, . vertigo, . glaucoma, . seizures, . multiple sclerosis, . muscle spasticity, and . any other illness, condition or disorder for which the Minister for Health in consultation with the Pharmaceutical Services Branch (PSB) of the NSW Health Department is satisfied medical cannabis may form an appropriate part of palliative or therapeutic treatment.

Cannabis in tincture form consists of a liquid concentration of cannabis, where the tetrahydrocannabinol (THC) and cannabinoids have been leached out into alcohol. Cannabis tincture is administered orally.

Medical cannabis in tincture form is the preferred option to resolve the concerns related to the significant negative health impacts associated with smoking raw cannabis and to provide superior control and reliability in drug delivery.

Administration in tincture form circumvents the negative side effects of smoking. Cannabis in tincture form has proved to have low uptake amongst recreational users because it lacks some of the effects obtainable from smoking cannabis.

By setting tightly controlled prerequisites for participation in the proposal trial, including prescription for a listed diagnosis approved by NSW Health, and by limiting the form of cannabis prescribed to tincture form, the proposed trial effectively eliminates the risk of stimulating the recreational market.

The design of this scheme is aimed at assisting people suffering chronic illness in NSW by making legally available a clinically proved therapeutic and palliative medical remedy. Unlike the approach taken in the United States where 'medical marijuana' has provided a backdoor route to de facto legalisation of recreational cannabis use, the proposed trial in NSW is limited in its scope and properly aimed at those people who could benefit from the administration of medical cannabis.

Background'Medicinal cannabis', 'medical cannabis' or 'medical marijuana' refers to the use of the active ingredient of cannabis, THC, as a physician-prescribed palliative or therapeutic treatment.

Cannabis has twenty one chemically-related carbon alkaloids which are called cannabinoids, of which the most notable are delta-9 tetrahydrocannabinol and cannabidiol. Cannabinoids act as moderate analgesics with low toxicity and they have a potency several times that of codeine and have a longer duration in the body. 'Cannabinoids' also refer to pharmaceutical quality drugs that act in the same way in the body as cannabis substances. Two such drugs are nabilone, which is THC in a capsule form (available in the UK) and dronabinol which is synthetic THC (available in the US).

The increasing rate of research into medical cannabis and accompanying clinical trials being conducted across the developed world have already changed perceptions in the medical profession and are now driving momentum for law reform in Australian jurisdictions and abroad.

Medical Benefits: Therapeutic and Palliative

Cannabis has a long tradition of medical uses that appears to begin in India over 4000 years ago. Today, both the therapeutic and palliative benefits of cannabis are recognised amongst health professionals and medical practitioners.

Prescription of medical cannabis as a palliative treatment is most common in relation to HIV and all forms of cancer, and in particular to relieve pain associated with chemotherapy treatment.

The Medical Profession's PositionThe Royal College of Physicians supports further studies

In 2005 the Royal College of Physicians commissioned a working party to investigate the benefits and risks of medical cannabis as a palliative and therapeutic treatment option.

The resulting report, Cannabis and cannabis-based medicines: Potential benefits and risks for health [1], found that there is scientific evidence to support further studies of the use of THC in multiple sclerosis and in the management of other forms of chronic pain. The report considered the pharmacological effect of cannabinoids (a number of natural and synthetic compounds), their efficacy in comparison with other medicines, the results of clinical trials, the safety of cannabis and possible links between cannabis and psychosis.1 http://www.rcplondon.ac.uk/news-media ... ts-and-need-further-study

The American Medical Association affirmed benefits and called for further studiesIn November 2009 the American Medical Association (AMA) voted to reverse its long-held position that marijuana be retained as an illicit Schedule I substance with no medical value. The Association adopted a report drafted by the AMA Council on Science and Public Health (CSAPH) entitled, Use of Cannabis for Medicinal Purposes [2], which affirmed the therapeutic benefits of marijuana and called for further research. The report noted that the results of short term controlled trials indicate that smoked cannabis reduces neuropathic pain, improves appetite and caloric intake especially in patients with reduced muscle mass, and may relieve spasticity and pain in patients with multiple sclerosis. 2 http://www.ama-assn.org/resources/doc/csaph/i09csaph3ft.pdf

The Australian Medical Association remains cautious but supports researchThe Australian Medical Association remains more cautious in embracing the growing global shift towards recognising the therapeutic and palliative benefits of medical cannabis, however, has not ruled out endorsing a trial of medical cannabis in Australia.The Association considers cannabis may be of medical benefit in treating HIV and cancer-related wasting, and nausea and vomiting in people with cancer, including those undergoing chemotherapy treatment. However it believes that more research needs to be undertaken to determine the medical benefit of cannabis in treating neurological disorders including (but not limited to) multiple sclerosis and motor neurone disease [3]. 3 http://ama.com.au/node/2556

The Australian Medical Association supports research to examine whether cannabinoids provide any greater benefit than the newer antiemetics [4]. 4 Drug that is effective against vomiting and nausea.

Aborted Medical Cannabis Trials in NSWIn 1999 the NSW Drugs Summit recommended a medical cannabis trial be conducted in NSW. Then Premier Bob Carr responded by convening a Working Party which reported in August 2000 on the uses of cannabis for medical purposes [5]. 5 Seehttp://www.druginfo.nsw.gov.au/medici ... _cannabis_nsw/canrep1.pdf

In May 2003 the Carr government outlined its response to the report including the establishment of an Office of Medicinal Cannabis and a proposed four-year trial. The government failed to reveal details about how the trial would operate, pre-empting its failure to eventuate in practice. Since 2004 no progress has been made by the NSW Government towards advancing a medical cannabis trial in NSW.

Appendix A: The Greens Motion in the NSW Upper House412. Dr Kaye to move---1. That this House:(a) notes the increasing body of peer-reviewed scientific and medical research which substantiates the palliative and therapeutic benefits of cannabis and cannabinoid drugs,(b) notes that the Carr Government's 1999 Drug Summit recommended a trial of medical cannabis which has not yet been implemented, and(c) calls the Minister for Health to establish a medical trial in New South Wales, including assessing and addressing any legislative and jurisdictional barriers to this trial.2. That this House notes that the medical cannabis trial established by the Minister for Health would confirm to the following principles: (a) any benefits or side effects identified,(b) any legal barriers encountered and how they were addressed, and(c) any barriers to the permanent establishment of a medical marijuana scheme in New South wales and how they may be addressed. (Notice given 23 November 2011---expires Notice Paper No. 77)

Appendix B: NSW Greens Policy, Drugs and Harm Minimisation39. Allow drugs to be regulated and prescribed for medicinal purposes based only on their therapeutic and palliative effects.

The discussion paper includes evidence on the therapeutic and palliative benefits of medicinal cannabis and outlines the parameters of how a trial could be undertaken in NSW.